Trial Investigating Efficacy of G-POEM (G-POEM)

Randomized Sham-controlled Trial Investigating Efficacy of Gastric Peroral Endoscopic Myotomy in Treatment of Diabetic Gastroparesis

The goal of this randomized sham-controlled trial is to ivestigate efficacy and safety of G-POEM in treatment of diabetic gastroparesis and explore impact of G-POEM on glucose metabolism and incretine hormones.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis With Diabetes Mellitus
• Intervention / Treatment: Procedure: G-POEM; Procedure: Sham

Detailed Description

Study Design The study is a single-centre double-blinded sham-controlled randomized trial. All patients have the same baseline characterization. Patients and researchers will be blinded to allocation in trial. Before randomization patients will have an additional meal test performed addressing metabolic characterization of the incretine hormones at baseline. Patients will afterwards be allocated to either the group receiving G-POEM or to the control group where a sham procedure consisting of a gastroscopy with biopsy during general anaesthesia will be done. The randomization will be carried out per-operatively. A computer-generated bloc randomization with sizes of four will be applied. The study will consist of 5 study visits, with a follow-up of 90 days after procedure. Symptoms and adverse event will be monitored 7, 30, and 90 days after intervention. During the 90-day follow-up all primary and secondary outcome will be reassessed.

G-POEM procedure is carried out in general anaesthesia in the operating theatre at the Department of Surgery, Hvidovre Hospital. Procedures will be performed by experienced surgeons from the Gastro Unit at Hvidovre Hospital,who postoperatively will have no contact with the research team or study participants. Patients will receive the same care during hospitalization.

Patients allocated to sham procedure will have 4 mucosa biopsies from antrum. All biopsies will be handled with formalin and transported to Zealand University Hospital. Here they will be formalin fixed paraffin-embedded and kept in a biobank.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John G Karstensen; Phone Number: +4540944465; Email: john.gasdal.karstensen@regionh.dk

Study Locations

• Denmark
  • Region Hovedstaden
    • Hvidovre, Region Hovedstaden, Denmark, 2650
      • Recruiting
      • Melina Svraka Hansen
      • Contact: Melina S Hansen; Phone Number: +4528304757; Email: melina.svraka.hansen.01@regionh.dk
      • Contact: John PE myotomy; Phone Number: +4540944465; Email: john.gasdal.karstensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The ability to give signed written informed consent,
• Patients with diabetes and gastroparesis,
• Age >18 years,
• Gastroparesis is diagnosed with technetium-scintigraphy,
• Normal gastroscopy,

Exclusion Criteria:

• Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator,
• Recent gastrointestinal surgery,
• Active duodenal/gastric ulcer disease,
• Diseases in the ventricle or previously complicated upper abdominal surgery,
• Previous bariatric surgery,
• Pregnancy or breastfeeding,
• Parkinson disease,
• Persons who, in the judgement of the investigator, may be unable to follow the protocol, Use of metoclopramide, domperidone, prucalopride, ghrelin, macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin) during study period.
• drugs with an anti-cholinergic mechanism,
• Use of motility slowing agents: anticholinergic agents, calcium channel blockers, TCA, GLP-1 analogs, Lithium, diphenhydramin, glucagon, dopamine agonists, progesterone, L-dopa, calcitonine, octreotide, interferon alfa, sucralsulfate,
• botulinum toxin injections (eg, Botox®) by pyloric injection less than 4 months prior to procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: G-POEM procedure; Gastric peroral endoscopic myotomy	Procedure: G-POEM; An Endoscopic submucosal tunnel is formed and extended to the first part of the duodenum, followed by a pyloromyotomy, beginning approximately two centimetres proximal to the pylorus and ending in the first part of duodenum.
Placebo Comparator: Sham procedure; sham endsocopy with biopsy	Procedure: Sham; Endoscopy is performed and tissue samples are collected from fundus and antrum as part of the Sham procedure; Other Names: Endoscopy with tissue sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gastric emptying	assessed by technetium scintigraphy	90 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gastroparesis cardinal symptom index (GCSI)	patient-rated gastroparesis cardinal symptom index score for gastroparesis-related symptoms (naseau, vomiting, early satiety, postprandial fulness, upper abdominal pain). Range from 0-none to 5-very servere.	7, 30 and 90 days after intervention.
Changes in Plasma glucose	concentration of plasma glucose in mmol/L	90 days after intervention.
Changes in postprandial incretinhormones	gastrin, CCK, GIP, GLP-1, GLP-2, glucagon, ghrelin, pancreatic polypeptide (PP)	90 days after intervention.
Concentration of C-peptide in pmol/L	Concentration of C-peptide in pmol/L	90 days after intervention.
Changes in continuous glucose	Measure of 10-days interstitial glucose levels with a Dexcom monitor device attached to the abdominal skin	90 days after intervention.
Incidence of Treatment-Emergent Adverse Events rated by the ASGE lexicon for adverse events	rate and severity of adverse events rated by the ASGE lexicon for adverse events	7,30 and 90 days

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Zealand University Hospital; Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: John G Karstensen, MD, Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: gastroparesis; G-POEM; gastric peroral endoscopic myotomy; technetium-scintigraphy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: SJ-981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No